Vioxx high-risk warning no surprise in medical circles

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Vioxx high-risk warning no surprise in medical circles

 

Vioxx high-risk warning no surprise in medical circles

 

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Thu Sep 30, 3:21 PM ET

 

WASHINGTON (AFP) - US drug company Merck's withdrawal of the

blockbuster arthritis drug Vioxx from markets due to the risk of

stroke and heart attack came as no surprise in medical circles, where

Vioxx alarm bells were ringing two years ago.

 

Vioxx, marketed in more than 80 countries with sales of 2.5 billion

dollars in 2003, was shown to heighten the risk of stroke and heart

attack in a study of patients taking the drug in a Merck internal

trial to evaluate its effectiveness against colorectal polyps.

 

In July, an independent study showed a high dose of Vioxx increased

hypertension and the risk of heart attack.

 

The researchers of that study had already warned in 2002, in a study

covered in the British journal Lancet, that patients taking a high

dose of Vioxx -- 50 mg -- ran nearly twice the risk of stroke and

heart attack as well as death linked to heart disease.

 

Dr Marie Griffin of Vanderbilt University Medical Center in Nashville,

Tennessee, who ran those studies, said Merck's withdrawal of Vioxx

" was a good decision from a public standpoint. "

 

Although Vioxx increases patient comfort, she told AFP, " the drug does

not save lives " -- the deciding factor in determining whether a drug's

benefits outweigh its undesirable effects.

 

Merck withdrew Vioxx based on the results of an internal three-year

study of 2,600 patients, half of whom received a 25 mg dose of Vioxx

and half of whom received a placebo.

 

The company said these patients, treated with Vioxx to thwart the

resurgence of colorectal polyps, a common precursor to cancer, showed

no undesirable effects during the first 18 months of the study begun

in 2000.

 

However, said Peter Kim, president of Merck Research Laboratory,

" while the cause of these results is uncertain at this time, they

suggest an increased risk of confirmed cardiovascular events beginning

after 18 months of continuous therapy. "

 

Merck chairman Raymond Gilmartin told the CNBC financial television

network that there had been a total of 10 deaths during the Merck

study -- five among those taking Vioxx and five among the placebo

takers. Merck published no details on the causes of these deaths.

 

The decision to withdraw Vioxx will doubtless benefit Pfizer's

Celebrex, another top-selling prescription anti-inflammatory drug for

treating arthritis.

 

Pfizer, also a US manufacturer, reacted to Merck's decision by

pointing out that Celebrex patients showed no elevated risk of stroke

or heart attack.

 

Vioxx (rofecoxib) and Celebrex (celecoxib) are part of a class of

drugs that

inhibit the enzyme COX-2, thereby blocking inflammation.

 

However, Vanderbilt's Griffin, who did not participate in the Merck

study, said " Vioxx seems to behave differently; it causes more high

blood pressure.

 

" The drugs (in that class) are structurally different. Celebrex is

more likely to cause a skin rash. "

 

" We have alternatives that are safe, " she said.

 

 

2004 Agence France Presse. All rights reserved. The

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